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510(k) Data Aggregation
(75 days)
Filtration of exhaled gases in the ventilator circuit.
Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators.
Cleaning method -- autoclaved -- 30 minutes with 3 minutes at 134°C.
Environment of Use --Hospital, Sub-acute Institutions
The Air Safety Model 3000/06 HEPA filter is a multi-use, reusable ventilator in-line filter which The An Bareey Indust side of the PB 700 series and 7200 ventilators. It can be cleaned by steam ecomeets in the ennation are 1 year service life. It has standard 22 mm tubing connectors and it has a clear housing. It contains the Air Safety standard Multipleat media which has been HEPA tested for enting performance according to BS 3928 Sodium Flame for Air filters and in accordance to DOE 3202-97 and ASTM D2986 - DOP. In addition BFE and VFE testing has been performed by 1902 5202 77 and in the substantial equivalence to the predicate devices.
This response describes the acceptance criteria and the study that indicates the device meets the acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Devices) | Reported Device Performance (Air Safety Model 3000/06) |
|---|---|---|
| Indications for use | To filter expired gases. | Same |
| Extended use | Up to 15 days continuous, reusable up to 100 times via autoclave or 1 year service life | Yes (Matches predicate) |
| Prescription | Yes | Yes (Matches predicate) |
| Intended population | Any patient on a ventilator - PB 700 series and 7200 | Any patient on a ventilator - PB 700 series and 7200 |
| Intended Environment of Use | Hospital, sub-acute institution | Hospital, sub-acute institution |
| Placement in exhalation limb of circuit | Yes | Yes (Matches predicate) |
| Reusable housing and materials | Yes | Yes (Matches predicate) |
| Clean by autoclave | Yes | Yes (Matches predicate) |
| Standard 15/22 mm connectors | Yes | Yes (Matches predicate) |
| Dead Space (ml) | ~ 350 ml | ~ 350 ml |
| Resistance to flow | 99.97% of 0.3 micron DOP particle) | Yes (Matches predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size in terms of the number of devices or units tested for each performance characteristic. Instead, it refers to the performance of the predicate devices and implies that the Air Safety Model 3000/06 HEPA Filter matches these established performance characteristics.
The provenance of the data is primarily from Nelson Lab for the Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE) testing. The document also refers to testing performed according to BS 3928 Sodium Flame for Air filters and in accordance with DOE 3202-97 and ASTM D2986 - DOP. The context suggests these are retrospective references to established standards and predicate device performance, rather than a prospective, independently designed clinical trial specifically for the 3000/06 model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not specify the number or qualifications of experts used to establish a "ground truth" for a specific test set. The data presented is engineering and laboratory performance data (e.g., filtration efficiency, resistance to flow) measured against established industry standards and specifications, rather than clinical outcomes requiring expert consensus on a patient-level "ground truth."
4. Adjudication Method for the Test Set
Not applicable. The evaluation relies on direct measurements against predefined technical specifications and standards, not on subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic imaging devices where human readers interpret patient cases, and the AI's impact on their performance is evaluated. The Air Safety Model 3000/06 is a physical filter, not a diagnostic tool that involves human interpretation of cases.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The performance metrics listed (e.g., BFE, VFE, resistance to flow, dead space) are inherent properties of the device itself, measured independently of human interaction in typical clinical use. The "study" here refers to the laboratory testing conducted to ascertain these physical and filtration properties against established standards.
7. Type of Ground Truth Used
The "ground truth" for the performance claims is based on established engineering and laboratory standards and predicate device specifications. For example:
- Bacterial and Viral Filtration Efficiency: Determined by testing performed by Nelson Lab, likely against a standardized challenge (e.g., specific bacterial/viral aerosols) under controlled laboratory conditions.
- Resistance to Flow: Measured using standardized methodologies relevant to ventilator circuits (e.g., flow rates of 60 lpm and 100 lpm).
- HEPA testing: Performance according to BS 3928 Sodium Flame for Air filters and DOE 3202-97 and ASTM D2986 - DOP, which specify testing procedures and filtration efficiency requirements for particulate matter.
8. Sample Size for the Training Set
Not applicable. This device is a physical filter being evaluated against quantifiable performance metrics, not an AI model that requires a "training set" for machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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